Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent

This study has been terminated.
(Discontinued PB127 development program for business reasons)
Sponsor:
Information provided by:
Point Biomedical
ClinicalTrials.gov Identifier:
NCT00584714
First received: December 20, 2007
Last updated: July 1, 2008
Last verified: July 2008
  Purpose

The purpose of this study is to collect longer term follow-up information concerning health and survival on selected patients who received PB127 for injectable suspension in the pivotal trial (127-014).


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent

Resource links provided by NLM:


Further study details as provided by Point Biomedical:

Primary Outcome Measures:
  • To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with low/very low pre-test probability of coronary artery disease enrolled in Protocol 127-014 who did not have or were not schedule to undergo coronary angiography at the time of enrollment and did not have a clinical outcome during the initial 6 month follow-up period.

Criteria

Inclusion Criteria:

Patients enrolled in Protocol 127-014 who

  1. Were enrolled in Stratum 1
  2. Did not undergo angiography during study evaluation
  3. Did not have a clinical oucome during the initial 6 month follow-up period as described in Protocol 127-014.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584714

  Hide Study Locations
Locations
United States, Arizona
University of Arizona Saver Heart Clinic
Tucson, Arizona, United States, 85724
United States, California
Cardiovascular Associates of the Peninsula
Burlingame, California, United States, 94010
Long Beach VA Medical Center Cardiology Division
Long Beach, California, United States, 90822
Cedars Sinai Medical Center Division of Cardiology
Los Angeles, California, United States, 90048
Sutter Roseville Medical Center
Roseville, California, United States, 95661
University of California San Diego Division of Cardiology
San Diego, California, United States, 92103
San Francisco VA Medical Center NCIRE
San Francisco, California, United States, 94121
United States, Connecticut
Connecticut Clinical Research
Bridgeport, Connecticut, United States, 06606
United States, Delaware
Alfieri Cardiology
Newark, Delaware, United States, 19713
United States, District of Columbia
Washington Hospital Center Cardiovascular Research Institute
Washington, District of Columbia, United States, 20010
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Kansas
Midwest Cardiology Associates
Overland Park, Kansas, United States, 66209
The Center for Cardiovascular Studies Kramer & Crouse Cardiology
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Western Baptist Hospital The Heart Group
Paducah, Kentucky, United States, 42001
United States, Maine
Androscoggin Cardiovascular Associates
Auburn, Maine, United States, 04210
Maine Cardiology Associates
South Portland, Maine, United States, 04106
United States, Massachusetts
Brigham & Women's Hosptial
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States
United States, Minnesota
Mayo Clinic Department of Cardiology
Rochester, Minnesota, United States, 55905
United States, Missouri
Cardiovascular Consultants
Kansas City, Missouri, United States, 64111
St. Louis University Medical Center
St. Louis, Missouri, United States, 63110
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
St. Luke's Roosevelt Hospital Echocardiography Lab
New York, New York, United States, 10025
Stonybrook University Medical Center
Stonybrook, New York, United States, 11794
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Carolina Cardiology Associates
High Point, North Carolina, United States, 27262
United States, Ohio
The Cleveland Clinic Foundation Department of Cardiology
Cleveland, Ohio, United States, 44195
Ohio State University College of Medicine and Public Health
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Cardiovascular Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Austin Heart
Austin, Texas, United States, 78705
Seton Healthcare Network Brackenridge Hospital
Austin, Texas, United States, 78701
Consultants in Cardiology
Fort Worth, Texas, United States, 76104
University of Texas Division of Cardiology
Galveston, Texas, United States, 77555
University of Texas Health Science Center Memorial Hermann Heart & Vascular Institute
Houston, Texas, United States, 77030
Methodist DeBakery Heart Center Cardiovascular Imaging Institute
Houston, Texas, United States, 77030
United States, Washington
Harborview Medical Center Department of Cardiology
Seattle, Washington, United States, 98104
Heart Clinics Northwest
Spokane, Washington, United States, 99204
Inland Cardiology
Spokane, Washington, United States, 99204
Northwest Cardiovascular Research Institute Spokane Cardiology
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Point Biomedical
Investigators
Study Director: Alexander Ehlgen, MD, PhD POINT Biomedical Corp.
  More Information

No publications provided

Responsible Party: Tom Ottoboni PhD/Chief Operating Officer, POINT Biomedical Corp.
ClinicalTrials.gov Identifier: NCT00584714     History of Changes
Other Study ID Numbers: 127-014-A
Study First Received: December 20, 2007
Last Updated: July 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Point Biomedical:
ultrasound
perfusion
SPECT
coronary artery disease
chest pain
low probability
angiography
clinical outcomes

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014